Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 085266
Company: MD PHARM
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DI-ATRO ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE 0.025MG;2.5MG TABLET;ORAL Discontinued None No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
04/18/1977 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/30/1992 SUPPL-71 Labeling

Label is not available on this site.

04/05/1989 SUPPL-70 Labeling

Label is not available on this site.

10/18/1988 SUPPL-69 Labeling

Label is not available on this site.

05/25/1988 SUPPL-68 Labeling

Label is not available on this site.

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